Skip to content

Ta-20 Automatic Industiral Audiometer

by Teledyne Avionics Div. of Teledyne

510(k) K851015

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK851015 Date4 Jun 1985ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
EWO
Device Class
Class II
Regulation
21 CFR Part 874.1050
Advisory Committee
Ear, Nose, Throat
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Ta-20 Automatic Industrial Audiometer is an audiometer, a device used to assess hearing. It is classified as a device with a device class of 2.

The Ta-20 Automatic Industrial Audiometer is supplied with FDA 510K clearance, with the regulation number 874.1050 and product code EWO. It is used in the medical specialty of Ear, Nose, Throat.

Other devices from Teledyne Avionics Div. of Teledyne

See all devices from Teledyne Avionics Div. of Teledyne →

Questions

AI-generated answers, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the TA-20 Automatic Industrial Audiometer used for?

    The TA-20 Automatic Industrial Audiometer is used to assess hearing in the medical specialty of Ear, Nose, Throat.

  • Is the TA-20 Automatic Industrial Audiometer supplied with regulatory clearance?

    Yes, the TA-20 Automatic Industrial Audiometer is supplied with FDA 510K clearance, with the regulation number 874.1050 and product code EWO.

  • What device class is the TA-20 Automatic Industrial Audiometer classified as?

    The TA-20 Automatic Industrial Audiometer is classified as a device with a device class of 2.